{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T12:12:38Z","timestamp":1792843958894,"version":"4.5.0"},"reference-count":54,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2023,11,20]],"date-time":"2023-11-20T00:00:00Z","timestamp":1700438400000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005416","name":"Norges Forskningsr\u00e5d","doi-asserted-by":"publisher","award":["275476"],"award-info":[{"award-number":["275476"]}],"id":[{"id":"10.13039\/501100005416","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Diab Res Care"],"accepted":{"date-parts":[[2023,9,13]]},"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>There is a need for simple and cheap diagnostic tools for diabetic polyneuropathy (DPN). We aimed to assess the diagnostic accuracy of the 5.07\/10 g monofilament test in patients referred to polyneuropathy assessments, as well as to examine how disease severity, age, sex and neuropathic pain (NP) impact diagnostic accuracy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Research design and methods<\/jats:title>\n                  <jats:p>Five Norwegian university hospitals recruited patients with diabetes aged 18\u201370 referred to neurological outpatient clinics for polyneuropathy assessments. The 5.07\/10 g Semmes-Weinstein monofilament examination (SWME) was validated against the Toronto consensus for diagnosing diabetic neuropathies; the results were stratified by age, sex and NP. Disease severity was graded by a combined nerve conduction study (NCS) Z-score, and logistic regression was applied to assess whether disease severity was a predictor of diagnostic accuracy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In total, 506 patients were included in the study. Global sensitivity was 0.60 (95% CI 0.55, 0.66), specificity 0.82 (95% CI 0.75, 0.87), positive and negative predictive values were 0.86 (95% CI 0.81, 0.90) and 0.52 (95% CI 0.46, 0.58), respectively, positive and negative likelihood ratios were 3.28 (95% CI 2.37, 4.53) and 0.49 (95% CI 0.42, 0.57), respectively. The SWME was less sensitive in females (0.43), had lower specificity in patients with NP (0.56), and performed worse in patients \u226550 years. NCS-based disease severity did not affect diagnostic accuracy (OR 1.15, 95% CI 0.95, 1.40).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This multicenter study demonstrates poor diagnostic performance for the 5.07\/10 g SWME in patients with diabetes referred to polyneuropathy assessments; it is particularly unsuited for female patients and those with NP. The diagnostic accuracy of the SWME was not influenced by NCS-based disease severity, demonstrating that it does not perform better in patients with later stages of DPN. We do not recommend the use of the 5.07\/10 g monofilament in the evaluation of patients with diabetes referred to polyneuropathy assessments.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjdrc-2023-003545","type":"journal-article","created":{"date-parts":[[2023,11,21]],"date-time":"2023-11-21T00:10:14Z","timestamp":1700525414000},"page":"e003545","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":11,"title":["Diagnostic accuracy of the 5.07 monofilament test for diabetes polyneuropathy: influence of age, sex, neuropathic pain and neuropathy severity"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1280-7656","authenticated-orcid":false,"given":"\u00d8ystein","family":"Dunker","sequence":"first","affiliation":[{"name":"Department of Research and Innovation, Oslo University Hospital, Oslo, Norway"},{"name":"Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway"},{"name":"Department of Neurology and Clinical Neurophysiology, Oslo University Hospital, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Uglem","sequence":"additional","affiliation":[{"name":"Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology Faculty of Medicine and Health Sciences, Trondheim, Norway"},{"name":"Department of Neurology and Clinical Neurophysiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Bu Kval\u00f8y","sequence":"additional","affiliation":[{"name":"Department of Neurology, Section of Clinical Neurophysiology, Stavanger University Hospital, Stavanger, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sissel","family":"L\u00f8seth","sequence":"additional","affiliation":[{"name":"Department of Neurology and Clinical Neurophysiology, University Hospital of North Norway, Troms\u00f8, Norway"},{"name":"Department of Clinical Medicine, The Artic University of Norway, Troms\u00f8, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ina Elen","family":"Hjelland","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurophysiology, Haukeland University Hospital, Bergen, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara Maria","family":"Allen","sequence":"additional","affiliation":[{"name":"Department of Neurology and Clinical Neurophysiology, Oslo University Hospital, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Dehli Vigeland","sequence":"additional","affiliation":[{"name":"Department of Research and Innovation, Oslo University Hospital, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inge Petter","family":"Kleggetveit","sequence":"additional","affiliation":[{"name":"Department of Neurology and Clinical Neurophysiology, Oslo University Hospital, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trond","family":"Sand","sequence":"additional","affiliation":[{"name":"Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology Faculty of Medicine and Health Sciences, Trondheim, Norway"},{"name":"Department of Neurology and Clinical Neurophysiology, St Olavs Hospital, Trondheim University Hospital, Trondheim, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristian Bernhard","family":"Nilsen","sequence":"additional","affiliation":[{"name":"Department of Research and Innovation, Oslo University Hospital, Oslo, Norway"},{"name":"Department of Neurology and Clinical Neurophysiology, Oslo University Hospital, Oslo, Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2023,11,20]]},"reference":[{"key":"2025073113175204000_11.6.e003545.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2021.109119"},{"key":"2025073113175204000_11.6.e003545.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2019.107843"},{"key":"2025073113175204000_11.6.e003545.3","doi-asserted-by":"publisher","DOI":"10.1007\/s10654-015-0094-6"},{"key":"2025073113175204000_11.6.e003545.4","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.6.1790"},{"key":"2025073113175204000_11.6.e003545.5","doi-asserted-by":"crossref","DOI":"10.1007\/s11892-019-1212-8","article-title":"Epidemiology of peripheral neuropathy and lower extremity disease in diabetes","volume":"19","author":"Hicks","year":"2019","journal-title":"Curr Diab Rep"},{"key":"2025073113175204000_11.6.e003545.6","doi-asserted-by":"crossref","first-page":"167","DOI":"10.7326\/M20-1340","article-title":"Peripheral neuropathy and all-cause and cardiovascular mortality in U.S. adults: a prospective cohort study","volume":"174","author":"Hicks","year":"2021","journal-title":"Ann Intern Med"},{"key":"2025073113175204000_11.6.e003545.7","doi-asserted-by":"crossref","first-page":"1043","DOI":"10.1007\/s40279-021-01596-6","article-title":"Exercise and neuropathy: systematic review with meta-analysis","volume":"52","author":"Streckmann","year":"2022","journal-title":"Sports Med"},{"key":"2025073113175204000_11.6.e003545.8","doi-asserted-by":"publisher","DOI":"10.2337\/dc19-S011"},{"key":"2025073113175204000_11.6.e003545.9","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.l1108","article-title":"Diagnosis and management of sensory polyneuropathy","volume":"365","author":"Gwathmey","year":"2019","journal-title":"BMJ"},{"key":"2025073113175204000_11.6.e003545.10","doi-asserted-by":"crossref","DOI":"10.3389\/fendo.2021.671257","article-title":"Advances in screening, early diagnosis and accurate staging of diabetic neuropathy","volume":"12","author":"Carmichael","year":"2021","journal-title":"Front Endocrinol (Lausanne)"},{"key":"2025073113175204000_11.6.e003545.11","doi-asserted-by":"crossref","DOI":"10.3389\/fendo.2021.719356","article-title":"Gold standard for diagnosis of DPN","volume":"12","author":"Yu","year":"2021","journal-title":"Front Endocrinol (Lausanne)"},{"key":"2025073113175204000_11.6.e003545.12","doi-asserted-by":"publisher","DOI":"10.2337\/dc10-1303"},{"key":"2025073113175204000_11.6.e003545.13","doi-asserted-by":"publisher","DOI":"10.1212\/CPJ.0b013e3182a78fb1"},{"key":"2025073113175204000_11.6.e003545.14","unstructured":"National Institute for Health and Care Excellence (NICE) . Diabetic foot problems: prevention and management 2015. 2019. Available: https:\/\/www.nice.org.uk\/guidance\/ng19\/chapter\/Recommendations#assessing-the-risk-of-developing-a-diabetic-foot-problem [Accessed 1 Sep 2022]."},{"key":"2025073113175204000_11.6.e003545.15","unstructured":"Helsedirektoratet . Unders\u00f8kelse Og Diagnostikk AV Nevropati Og Identifisering AV Pasienter MED Risiko for Fots\u00e5r. 2016. Available: https:\/\/www.helsedirektoratet.no\/retningslinjer\/diabetes\/diabetisk-fot-og-nevropati\/undersokelse-og-diagnostikk-av-nevropati-og-identifisering-av-pasienter-med-risiko-for-fotsar [Accessed 1 Sep 2022]."},{"key":"2025073113175204000_11.6.e003545.16","doi-asserted-by":"crossref","DOI":"10.1155\/2017\/8787261","article-title":"Diagnostic accuracy of monofilament tests for detecting diabetic peripheral neuropathy: a systematic review and meta-analysis","volume":"2017","author":"Wang","year":"2017","journal-title":"J Diabetes Res"},{"key":"2025073113175204000_11.6.e003545.17","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2006.01.041"},{"key":"2025073113175204000_11.6.e003545.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.pain.2010.07.026"},{"key":"2025073113175204000_11.6.e003545.19","doi-asserted-by":"crossref","first-page":"136233","DOI":"10.1016\/j.neulet.2021.136233","article-title":"Cutaneous pain in disorders affecting peripheral nerves","volume":"765","author":"Stucky","year":"2021","journal-title":"Neurosci Lett"},{"key":"2025073113175204000_11.6.e003545.20","doi-asserted-by":"crossref","DOI":"10.3390\/diagnostics11020165","article-title":"Early detection of diabetic peripheral neuropathy: a focus on small nerve fibres","volume":"11","author":"Burgess","year":"2021","journal-title":"Diagnostics (Basel)"},{"key":"2025073113175204000_11.6.e003545.21","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2016-012799","article-title":"STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration","volume":"6","author":"Cohen","year":"2016","journal-title":"BMJ Open"},{"key":"2025073113175204000_11.6.e003545.22","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.j3751","article-title":"STARD for abstracts: essential items for reporting diagnostic accuracy studies in Journal or conference abstracts","volume":"358","author":"Cohen","year":"2017","journal-title":"BMJ"},{"key":"2025073113175204000_11.6.e003545.23","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1097\/j.pain.0000000000002793","article-title":"Accuracy of neuropathic pain measurements in patients with symptoms of polyneuropathy: validation of painDETECT, self-completed Leeds assessment of neuropathic symptoms and signs, and douleur neuropathique 4","volume":"164","author":"Dunker","year":"2023","journal-title":"Pain"},{"key":"2025073113175204000_11.6.e003545.24","doi-asserted-by":"publisher","DOI":"10.1016\/S0363-5023(78)80084-7"},{"key":"2025073113175204000_11.6.e003545.25","unstructured":"Legeforeningen . Retningslinjer for metoder i klinisk nevrofysiologi. Legeforeningen, 2020."},{"key":"2025073113175204000_11.6.e003545.26","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinph.2022.01.002"},{"key":"2025073113175204000_11.6.e003545.27","unstructured":"St\u00e5lberg S . PowerpackTM . n.d. Available: http:\/\/stalbergsoftware.com\/powerpack.aspx2022"},{"key":"2025073113175204000_11.6.e003545.28","doi-asserted-by":"crossref","first-page":"588","DOI":"10.1016\/j.jocn.2014.09.017","article-title":"Thermal quantitative sensory testing: a study of 101 control subjects","volume":"22","author":"Hafner","year":"2015","journal-title":"J Clin Neurosci"},{"key":"2025073113175204000_11.6.e003545.29","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1002\/mus.27445","article-title":"Which combined nerve conduction study scores are best suited for polyneuropathy in diabetic patients","volume":"65","author":"Dunker","year":"2022","journal-title":"Muscle Nerve"},{"key":"2025073113175204000_11.6.e003545.30","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000000492"},{"key":"2025073113175204000_11.6.e003545.31","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(96)00236-3"},{"key":"2025073113175204000_11.6.e003545.32","unstructured":"Scott Long J . Regression models for categorical and limited dependent variables. In: Advanced quantitative techniques in the social sciences. 1997: 7."},{"key":"2025073113175204000_11.6.e003545.33","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1994.03510330081039"},{"key":"2025073113175204000_11.6.e003545.34","doi-asserted-by":"crossref","unstructured":"Hosmer DW , Lemeshow S , Sturdivant RX . Applied logistic regression. John Wiley & Sons, 22 March 2013. doi:10.1002\/9781118548387","DOI":"10.1002\/9781118548387"},{"key":"2025073113175204000_11.6.e003545.35","doi-asserted-by":"publisher","DOI":"10.2337\/dc16-2042"},{"key":"2025073113175204000_11.6.e003545.36","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.5.606"},{"key":"2025073113175204000_11.6.e003545.37","doi-asserted-by":"crossref","first-page":"307","DOI":"10.3389\/fpubh.2017.00307","article-title":"Specificity, and predictive values: foundations, pliabilities, and pitfalls in research and practice","volume":"5","author":"Trevethan","year":"2017","journal-title":"Front Public Health"},{"key":"2025073113175204000_11.6.e003545.38","doi-asserted-by":"publisher","DOI":"10.1370\/afm.1016"},{"key":"2025073113175204000_11.6.e003545.39","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2011.02.005"},{"key":"2025073113175204000_11.6.e003545.40","doi-asserted-by":"crossref","DOI":"10.1155\/2017\/1467213","article-title":"A comparison of screening tools for the early detection of peripheral neuropathy in adults with and without type 2 diabetes","volume":"2017","author":"Brown","year":"2017","journal-title":"J Diabetes Res"},{"key":"2025073113175204000_11.6.e003545.41","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdiacomp.2003.12.006"},{"key":"2025073113175204000_11.6.e003545.42","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.diabres.2019.03.029","article-title":"Use of graded Semmes Weinstein Monofilament testing for ascertaining peripheral neuropathy in people with and without diabetes","volume":"151","author":"Olaiya","year":"2019","journal-title":"Diabetes Res Clin Pract"},{"key":"2025073113175204000_11.6.e003545.43","first-page":"1","article-title":"Aesthesiometry: quantification of cutaneous pressure sensation in diabetic peripheral neuropathy","volume":"25","author":"Holewski","year":"1988","journal-title":"J Rehabil Res Dev"},{"key":"2025073113175204000_11.6.e003545.44","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1177\/107110070002100609","article-title":"Sensory thresholds of normal human feet","volume":"21","author":"Jeng","year":"2000","journal-title":"Foot Ankle Int"},{"key":"2025073113175204000_11.6.e003545.45","doi-asserted-by":"crossref","first-page":"453","DOI":"10.1093\/ptj\/69.6.453","article-title":"Insensitivity, limited joint mobility, and plantar ulcers in patients with diabetes mellitus","volume":"69","author":"Mueller","year":"1989","journal-title":"Phys Ther"},{"key":"2025073113175204000_11.6.e003545.46","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(14)70102-4"},{"key":"2025073113175204000_11.6.e003545.47","doi-asserted-by":"crossref","first-page":"3278","DOI":"10.1177\/0300060518775244","article-title":"Easier operation and similar power of 10 G monofilament test for screening diabetic peripheral neuropathy","volume":"46","author":"Zhang","year":"2018","journal-title":"J Int Med Res"},{"key":"2025073113175204000_11.6.e003545.48","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.23.7.984"},{"key":"2025073113175204000_11.6.e003545.49","doi-asserted-by":"publisher","DOI":"10.1016\/j.diabres.2010.06.021"},{"key":"2025073113175204000_11.6.e003545.50","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-6576.2011.02426.x"},{"key":"2025073113175204000_11.6.e003545.51","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/S1067-2516(00)80061-7","article-title":"The durability of the Semmes-Weinstein 5.07 monofilament","volume":"39","author":"Yong","year":"2000","journal-title":"J Foot Ankle Surg"},{"key":"2025073113175204000_11.6.e003545.52","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1111\/jdi.13173","article-title":"Lumos for the long trail: strategies for clinical diagnosis and severity staging for diabetic polyneuropathy and future directions","volume":"11","author":"Himeno","year":"2020","journal-title":"J Diabetes Investig"},{"key":"2025073113175204000_11.6.e003545.53","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1111\/jdi.13386","article-title":"Point-of-care nerve conduction device predicts the severity of diabetic polyneuropathy: a quantitative, but easy-to-use, prediction model","volume":"12","author":"Kamiya","year":"2021","journal-title":"J Diabetes Investig"},{"key":"2025073113175204000_11.6.e003545.54","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.24.2.250"}],"container-title":["BMJ Open Diabetes Research &amp; Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjdrc-2023-003545","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,31]],"date-time":"2025-07-31T20:18:00Z","timestamp":1753993080000},"score":1,"resource":{"primary":{"URL":"https:\/\/drc.bmj.com\/lookup\/doi\/10.1136\/bmjdrc-2023-003545"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11]]},"references-count":54,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2023,11,20]]},"published-print":{"date-parts":[[2023,11]]}},"alternative-id":["10.1136\/bmjdrc-2023-003545"],"URL":"https:\/\/doi.org\/10.1136\/bmjdrc-2023-003545","relation":{},"ISSN":["2052-4897"],"issn-type":[{"value":"2052-4897","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11]]}}}